Brexpiprazole in Patients With Acute Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

Key facts

Study ID

NCT01810380

Run by

H. Lundbeck A/S

People needed

468

Starts

2013-03-01

Expected to finish

2014-12-01

Last updated by the study team

2017-03-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient has schizophrenia, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
• The patient has an acute exacerbation of psychotic symptoms and marked deterioration of usual function.
• The patient is willing to be hospitalised from the Screening Visit through Week 6.
• The patient will benefit from hospitalisation or continued hospitalisation for treatment of a current acute relapse of schizophrenia at study entry.
• The patient has a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding the current episode.
• The patient agrees to protocol-defined use of effective contraception.

You may not qualify if…

• The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other than schizophrenia established as primary diagnosis.
• The patient suffers from a current Axis II diagnosis (DSM-IV-TR™ criteria).
• The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
• The patient, in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
• The patient has clinically significant tardive dyskinesia or severe akathisia at enrolment.
• The patient has a history of neuroleptic malignant syndrome.
• The patient has any relevant medical history or current presence of systemic disease.
• The patient has, at the Screening Visit an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
• The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of brexpiprazole.
• The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
• Other inclusion and exclusion criteria may apply.

Where it is running

• US009 — Escondido, California, United States

Full record on ClinicalTrials.gov

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